Sevelamer


Generic Medicine Info
Indications and Dosage
Oral
Hyperphosphataemia in chronic kidney disease
Adult: In patients on haemodialysis or peritoneal dialysis, or for those not requiring dialysis: As sevelamer carbonate or sevelamer hydrochloride: Initially, 800-1,600 mg tid. Dose should be initiated based on serum phosphorus level: >5.5-<7.5 mg/dL: 800 mg tid; ≥7.5 mg/dL: 1,600 mg tid. Adjust the dose gradually by 800 mg tid increment every 2-4 weeks until achieving the desired serum phosphorus levels. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Child: As sevelamer carbonate: ≥6 years BSA ≥0.75-<1.2 m2: 800 mg tid, titrate by 400 mg tid every 2-4 weeks as necessary; BSA ≥1.2 m2: 1,600 mg tid, titrate by 800 mg tid every 2-4 weeks as necessary. Treatment and dosing recommendations may vary among individual products and between countries (refer to specific product guidelines).
Administration
Should be taken with food.
Reconstitution
Powder for oral susp: Disperse the contents of each 800 mg sachet in 30 mL of water and each 2,400 mg sachet in 60 mL of water. Instruction for reconstitution may vary among local guidelines (refer to specific country guidelines).
Contraindications
Hypophosphataemia, bowel obstruction.
Special Precautions
Patient with dysphagia, swallowing disorders, active inflammatory bowel disease, severe gastrointestinal motility disorders (e.g. untreated or severe gastroparesis, gastric contents retention, abnormal or irregular bowel motion, severe constipation), major gastrointestinal tract surgery; hypothyroidism. Pregnancy and lactation.
Adverse Reactions
Significant: Serious gastrointestinal tract inflammatory disorders (e.g. haemorrhage, obstruction, perforation, ulceration, necrosis, colitis, colonic or caecal mass), peritonitis, metabolic acidosis; dysphagia and oesophageal tablet retention (tab).
Gastrointestinal disorders: Nausea, vomiting, abdominal pain, constipation, dyspepsia, diarrhoea, flatulence.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Monitoring Parameters
Obtain serum Ca, phosphorus and PTH as clinically indicated. Monitor serum chemistries including chloride and bicarbonate. Assess serum vitamin A, D, E, K and folic acid levels.
Drug Interactions
May decrease the serum concentration of ciclosporin, mycophenolate mofetil, tacrolimus and levothyroxine. Decreases the bioavailability of ciprofloxacin. May increase phosphate levels with PPIs. May reduce the absorption of vitamins A, D, E, K and folic acid. Consider separating the timing of administration with other drugs where a decrease in the bioavailability of that drug would have a significant effect on its safety or efficacy.
Action
Description:
Mechanism of Action: Sevelamer is a polymer compound which acts by binding phosphate in the gastrointestinal tract thereby limiting absorption and reducing serum phosphate levels without changing the concentrations of Ca, Al or bicarbonate.
Pharmacokinetics:
Absorption: Not systemically absorbed.
Excretion: Via faeces.
Chemical Structure

Chemical Structure Image
Sevelamer

Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 3085017, 2-(Chloromethyl)oxirane; prop-2-en-1-amine. https://pubchem.ncbi.nlm.nih.gov/compound/Sevelamer. Accessed Oct. 24, 2023.

Storage
Store between 15-30°C. Protect from moisture.
MIMS Class
Antidotes & Detoxifying Agents
ATC Classification
V03AE02 - sevelamer ; Belongs to the class of drugs used in the treatment of hyperkalemia and hyperphosphatemia.
References
Anon. Sevelamer. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 23/03/2023.

Anon. Sevelamer. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 23/03/2023.

Buckingham R (ed). Sevelamer. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/03/2023.

Joint Formulary Committee. Sevelamer. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 23/03/2023.

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Renagel 800 mg Film Coated Tablets data sheet 20 June 2022. Medsafe. http://www.medsafe.govt.nz. Accessed 23/03/2023.

Renagel Tablet, Film Coated (Genzyme Corporation). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/03/2023.

Renvela 2.4 g Powder for Oral Suspension (Aventis Pharma Limited). MHRA. https://products.mhra.gov.uk. Accessed 23/03/2023.

Renvela Tablet 800 mg (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 23/03/2023.

Sevelamer Carbonate Amneal 800 mg Film-coated Tablets (Zentiva Pharma UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 23/03/2023.

Sevelamer Carbonate Tablet, Film Coated; Sevelamer Carbonate Powder, for Suspension (Winthrop U.S.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 23/03/2023.

Sevelamer Hydrochloride 800 mg Film-coated Tablets (Waymade PLC). MHRA. https://products.mhra.gov.uk. Accessed 23/03/2023.

Disclaimer: This information is independently developed by MIMS based on Sevelamer from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 MIMS. All rights reserved. Powered by MIMS.com
  • Renvela
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in
Exclusive offer for doctors
Register for a MIMS account and receive free medical publications worth $139 a year.
Already a member? Sign in